A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Number of Participants Who Experienced at Least One Adverse Event
研究概览
简要总结
The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have participated in P
- •Participants must be >=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease.
- •Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.
排除标准
- •Participants who discontinued from Study P04501 because they experienced a serious adverse event (SAE)
- •Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis
- •Participants taking tolcapone
- •Participants who are participating in any other clinical study
研究组 & 干预措施
Preladenant 5 mg BID
Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
干预措施: Preladenant (Drug)
Preladenant 5 mg BID
Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
干预措施: L-dopa (Drug)
Preladenant 5 mg BID
Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
干预措施: Other Parkinson's Disease treatments (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One Adverse Event
时间窗: Up to 42 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.
次要结局
- Absolute Duration of Dyskinesias(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)
- Total Sleep Time(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)
- Time Spent in the "on" State With no Dyskinesias(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)
- Time Spent in the "on" State With Troublesome Dyskinesias(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)
- Time Spent in "Off" State Per Day(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)
- Awake Time Per Day in the "on" State(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)
- Time Spent in the "on" State Without Troublesome Dyskinesia(Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36)